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Shijiazhuang Fourth Pharmaceutical’s Fluconazole Sodium Chloride Injection Has Passed Consistency Evaluation.

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Group Announcement

Time：2021-01-22

On January 21, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received notification that its Fluconazole Sodium Chloride Injection had been approved for passing the evaluation of consistency in quality and efficacy for generic drugs.

On January 21, Shijiazhuang No.4 Pharmaceutical Co., Ltd. received notification that its Fluconazole Sodium Chloride Injection had passed the evaluation for consistency in quality and therapeutic efficacy of generic drugs. To date, Shijiazhuang No.4 Pharmaceutical has had a total of 14 specifications across 10 varieties pass the national evaluation for consistency in quality and therapeutic efficacy of generic drugs—or be deemed to have passed such evaluation—placing it at the forefront of the industry in terms of both the number of products evaluated and the pace of progress.
It is reported that fluconazole is a broad-spectrum antifungal drug primarily used for the treatment or prevention of various fungal infections, including cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, and mucosal candidiasis. Fluconazole belongs to the triazole class of antifungal agents and is widely employed in clinical practice for the treatment and prevention of fungal infections. It is recommended as a first-line therapy for several types of candidiasis and for primary prevention of invasive fungal infections in domestic guidelines such as “Diagnosis and Treatment of Candidiasis: Expert Consensus,” “Guidelines for Diagnosis and Treatment of Invasive Fungal Infections in Critically Ill Patients,” and “Clinical Practice Guidelines for Invasive Fungal Diseases in Chinese Solid-Organ Transplant Recipients.” This drug is listed in both the National Essential Medicines List and the National Medical Insurance Catalogue.
Previously, in May 2020, two specifications—150mg and 50mg—of fluconazole tablets (Yilikang) manufactured by Shijiazhuang Fourth Pharmaceutical Company both passed the evaluation of consistency in quality and efficacy for generic drugs.
Over the past two years, Shijiazhuang No.4 Pharmaceutical has been steadily advancing in parallel across the development of innovative drugs, generic drugs, and active pharmaceutical ingredients, as well as in studies on bioequivalence evaluation, continuously stepping up its efforts and accumulating substantial achievements that are now beginning to bear fruit. At the start of the new year, three generic drug quality and efficacy consistency evaluation projects—Ambrisentan Hydrochloride Injection, Ciprofloxacin Lactate Sodium Injection, and Fluconazole Sodium Chloride Injection—have successively passed the generic drug quality and efficacy consistency evaluation. Among these, Ciprofloxacin Lactate Sodium Injection became the first among 83 companies nationwide producing the same product to pass the evaluation, while Fluconazole Sodium Chloride Injection marked the second such approval in China.

Keywords:

Shijiazhuang Four Pharmaceutical’s two products have successfully won bids in the national centralized procurement.

Shijiazhuang Fourth Pharmaceutical’s Ciprofloxacin Lactate Sodium Injection Becomes the First in China to Pass the Generic Drug Consistency Evaluation.

Shijiazhuang Four Pharmaceutical’s two products have successfully won bids in the national centralized procurement.

Shijiazhuang Fourth Pharmaceutical’s Ciprofloxacin Lactate Sodium Injection Becomes the First in China to Pass the Generic Drug Consistency Evaluation.